It's my belief that in most cases the FDA and other similar agencies permit companies and others to try products in practically any way they wish once those products are proven safe.
CVM is a company known to have a safe drug which the company almost always expresses the belief will be the answer to whatever is considered the new threat to mankind. They typically announce that they'll start a Phase 3 Trial against the disease. The FDA and SEC permit this in spite of the fact that in essentially all passed trials the drug was unsuccessful in every way except in achieving temporarily higher prices, and issuing a lot of stock.
I bring this up because I believe once the safety trial for the cream is complete, the company or others may conduct whatever trials they wish. Whether it's Mediq or OWCP running additional trials they may do practically anything they're willing to fund. If these trials were intended for approval by one or more Govt. agencies, the trial criteria would be subject to discussions with those agencies, but if the trial is intended to explore what the drug is capable of doing, I believe the design of the trial is largely up to the sponsor and the IRB to design.
I believe that a company like Mediq could use results from such a trial to sell such a product, even without Govt. approval provided the product is one that doesn't require Govt. approval. In that most cannabis based products don't require Govt. approval, this may be the tact being taken by OWCP and Mediq to prove the success of the products, whether it's proper to call them a drug, a nutraceutical, or a cosmetic.
The key is knowing the product is safe to use, the Phase 1 Trial should prove that. As to what follow on trials show, that will be up to the designers of the trials.
Gary
CVM is a company known to have a safe drug which the company almost always expresses the belief will be the answer to whatever is considered the new threat to mankind. They typically announce that they'll start a Phase 3 Trial against the disease. The FDA and SEC permit this in spite of the fact that in essentially all passed trials the drug was unsuccessful in every way except in achieving temporarily higher prices, and issuing a lot of stock.
I bring this up because I believe once the safety trial for the cream is complete, the company or others may conduct whatever trials they wish. Whether it's Mediq or OWCP running additional trials they may do practically anything they're willing to fund. If these trials were intended for approval by one or more Govt. agencies, the trial criteria would be subject to discussions with those agencies, but if the trial is intended to explore what the drug is capable of doing, I believe the design of the trial is largely up to the sponsor and the IRB to design.
I believe that a company like Mediq could use results from such a trial to sell such a product, even without Govt. approval provided the product is one that doesn't require Govt. approval. In that most cannabis based products don't require Govt. approval, this may be the tact being taken by OWCP and Mediq to prove the success of the products, whether it's proper to call them a drug, a nutraceutical, or a cosmetic.
The key is knowing the product is safe to use, the Phase 1 Trial should prove that. As to what follow on trials show, that will be up to the designers of the trials.
Gary
